WithdrawnNot Applicable

Urinary Catheter 'Fill and Flush' Valve: Safety, Effectiveness, Acceptability and Feasibility Trial

Stopped: No participants met all the inclusion criteria required within the recruitment time period

United Kingdom0Started 2022-02-13

Plain-language summary

The fill and flush valve (valve) is an automated valve which is designed to open in response to rising bladder pressure which occurs as the bladder becomes full. The valve is situated between the IDC and the drainage bag as a manual valve would be.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * IDC-users (urethral or suprapubic), over 18, who have had a catheter in situ for at least one month and use a manual valve or drainage bag to collect urine * Independent with catheter care needs (e.g. bag emptying or valve opening) * Able to transfer from bed to chair, stand and walk short distances unaided * Able to drink moderate levels of fluid (500mls in the first 2 hours and 150mls per hour thereafter) * Able to provide informed consent (self-report and research nurse assessment) * Usual medical provider provides confirmation of suitability Exclusion Criteria: * End stages of a terminal illness * Current treatment of urinary tract infection * Has been advised by a urologist against using a valve on clinical grounds * Lack of bladder sensation (e.g. unable to sense when bladder needs emptying) * Previous bladder surgery that could affect the integrity of the bladder * At known risk of autonomic dysreflexia

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety: Reliability

Timeframe: An average of 16 hours in total

Safety: Effectiveness

Timeframe: An average of 16 hours in total

Safety: Effectiveness

Timeframe: An average of 16 hours in total

Comfort

Timeframe: An average of 16 hours in total

Trial details

NCT IDNCT04243902

SponsorUniversity of Southampton

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-18

View on ClinicalTrials.gov More Indwelling Urinary Catheter Users trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.